Status:
ACTIVE_NOT_RECRUITING
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Lead Sponsor:
Eli Lilly and Company
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Detailed Description
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded ...
Eligibility Criteria
Inclusion
- Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
- Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
Exclusion
- Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
- Have a self-reported change in BW\>5 kilogram (kg) within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening.
- Have a history of chronic or acute pancreatitis
- Have any of the following cardiovascular conditions within 3 months prior to week 0.
- Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
- family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
- Any lifetime history of a suicide attempt
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06047548
Start Date
September 20 2023
End Date
May 1 2026
Last Update
April 18 2025
Active Locations (20)
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1
Cahaba Research - Pelham
Pelham, Alabama, United States, 35124
2
Velocity Clinical Research, Westlake
Los Angeles, California, United States, 90057
3
Southern California Dermatology, Inc.
Santa Ana, California, United States, 92701
4
Encompass Clinical Research
Spring Valley, California, United States, 91978